What is Quality by Design (QbD)?
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process... Read More
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Indication splitting in biopharma licensing
While licensing in bio pharmaceutical business, if licenses are issued to different partners based on indications or disease and therapy, then this concepts is known... Read More
What are the difference between regulatory affairs and pharmacovigilance working?
Posted on21 Feb 2024
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Pharmacovigilance professionals deals with the adverse effects, and regulatory professionals work on registration and regulation of drug. Pharmacovigilance professionals are focused on the science of... Read More
What are the key auditing standards in pharmaceutical industry?
A pharmaceutical audit is a systematic, independent examination of a pharmaceutical company’s operations and processes to ensure compliance with Good Manufacturing Practices (GMP), regulatory guidelines,... Read More
What is meaning of OEM in medical device industry?
OEM means original equipment manufacturer in medical device industry. But coming to regularly pronounced medical device industry terminology it is misleading. OEMs are manufacturers who... Read More
What is pediatric exclusivity?
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but need not do... Read More
What is meaning of Common Technical Document (CTD)?
The Common Technical Document (CTD) is a set of specification for application dossier for the registration of Medicines. And it is designed to be used... Read More
What is the meaning and significance of ‘First to File’ Generics?
The first to file generics submits a substantially completed Abbreviated New Drug Application to receive marketing exclusivity for 180 days. Let us understand the concept... Read More
What is a CDMO?
A Contract Development and Manufacturing Organization (CDMO) serves clients various services from drug development to contract manufacturing. Services offered by CMOs include, but are not limited... Read More
What is the difference between Market withdrawal and Product Recall?
Posted on04 Dec 2023
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Product Recalls are actions taken by a firm to remove a product from the market. by FDA request, or by FDA order, whereas Market withdrawal... Read More
What is difference between phase IIa and Phase IIb clinical trial?
Posted on04 Dec 2023
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Phase II studies are sometimes divided into Phase IIA and Phase IIB. Phase IIA is specifically designed to assess dosing requirements (how much drug should... Read More